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Center | Date | Time | Location |
---|---|---|---|
CDER | July 20, 2004 July 21, 2004 |
8:30 a.m. - 5 p.m. 8:30 a.m. - 5 p.m. |
Center for Drug
Evaluation and Research |
Agenda:
On July 20, 2004, the subcommittee will: (1) Receive topic updates for ongoing
activities pertaining to manufacturing science and quality by design; and (2)
discuss and provide comment on a Current Good Manufacturing Practice (cGMP)
risk model being developed at FDA.
On July 21, 2004, the subcommittee will: (1) Discuss and provide comments on a cGMP and quality system approach for the production of investigational new drugs (INDs) and (2) discuss and provide comments on manufacturing science and risk-based questions for new drug application chemistry, manufacturing and controls (NDA CMC) review process.
Background material and meeting information will become available no later than one business day before each meeting day (Simply select the appropriate committee link).
Procedure:
Interested persons may present data, information, or views, orally or in writing,
on issues pending before the committee. Written submissions may be made to the
contact person by July 13, 2004. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 1:30 p.m. on July 20, 2004, and between
approximately 11:30 a.m. and noon on July 21, 2004. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before July 13, 2004, and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the names
and addresses of proposed participants, and an indication of the approximate
time requested to make their presentation. Persons attending FDA's advisory
committee meetings are advised that the agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings
and will make every effort to accommodate persons with physical disabilities
or special needs. If you require special accommodations due to a disability,
please contact Hilda Scharen at least 7 days in advance of the meeting.
Contact Person:
Hilda Scharen, Center for Drug Evaluation and Research (HFD–21),
Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630
Fishers Lane, Rm. 1093), Rockville, MD 20857, 301–827–7001, e-mail:
scharenh@cder.fda.gov,or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington,
DC area), code 3014512539. Please call the Information Line for up-to-date information
on this meeting.
[ Full FR Notice ]